Trial Outcomes & Findings for Chemoradiation or Brachytherapy for Rectal Cancer (NCT NCT02017704)
NCT ID: NCT02017704
Last Updated: 2023-10-17
Results Overview
Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines: * Complete response - no remaining viable cancer cells * Moderate response - only small clusters/single cancer cells remain * Minimal response - residual cancer remaining, but with predominant fibrosis * Poor response - minimal/no tumor kills, extensive residual cancer
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 60 months
Results posted on
2023-10-17
Participant Flow
Participant milestones
| Measure |
IMRT and Capecitabine
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
IMRT and Capecitabine
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Chemoradiation or Brachytherapy for Rectal Cancer
Baseline characteristics by cohort
| Measure |
IMRT and Capecitabine
n=4 Participants
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 Participants
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white/caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
met baseline enrollment requirements as per protocol
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPathologic complete response rate is reported as the number of patients who achieve pathologic complete response after the treatment for each arm. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines: * Complete response - no remaining viable cancer cells * Moderate response - only small clusters/single cancer cells remain * Minimal response - residual cancer remaining, but with predominant fibrosis * Poor response - minimal/no tumor kills, extensive residual cancer
Outcome measures
| Measure |
IMRT and Capecitabine
n=2 Participants
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 Participants
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Number of Patients With Pathologic Complete Response
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsNumber of participants with grade 3 or higher adverse events will be listed by relationship. Grading is by CTCAE 4 guidelines. Relationship, as determined by PI, is unrelated/unlikely/possible/probable/definite.
Outcome measures
| Measure |
IMRT and Capecitabine
n=2 Participants
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 Participants
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
Grade: 3; Relationship: probable
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Grade: 3; Relationship: possible
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Grade 3; Relationship: Unlikely
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, preop, postop, and at follow ups Y1-5Population: 3 patients randomised to IMRT arm had at least 1 form completed. 5 patients randomised to the ENDO arm had at least 1 form completed.
Patients were given the EORTC QLQ-C30 at baseline, preop, postop, and at follow ups Y1-5. The forms were scored as per the manual available at EORTC. Raw scores are transformed to fall in a range of 0-100. Generally, higher scores on QoL scales represent higher levels of QoL. The scores are reported as the mean of the Global Health Status/QoL scale score when more than 1 patient completed the form for a time point. If only 1 form was available for a time point, then the score for that form is reported.
Outcome measures
| Measure |
IMRT and Capecitabine
n=3 Participants
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 Participants
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection
Endo-HDR (if randomized to this arm): Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Change in EORTC QLQ-C30 Global Health Status Score
baseline
|
83 score on a scale
Interval 83.0 to 83.0
|
71.2 score on a scale
Interval 41.0 to 83.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
pre-op
|
33 score on a scale
Interval 33.0 to 33.0
|
49.6 score on a scale
Interval 8.0 to 83.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
post-op
|
54 score on a scale
Interval 33.0 to 75.0
|
72.5 score on a scale
Interval 50.0 to 91.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
year 1
|
—
|
73 score on a scale
Interval 33.0 to 100.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
year 2
|
50 score on a scale
Interval 50.0 to 50.0
|
66.3 score on a scale
Interval 33.0 to 83.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
year 3
|
66.5 score on a scale
Interval 50.0 to 83.0
|
77.3 score on a scale
Interval 66.0 to 83.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
year 4
|
83 score on a scale
Interval 83.0 to 83.0
|
91 score on a scale
Interval 91.0 to 91.0
|
|
Change in EORTC QLQ-C30 Global Health Status Score
year 5
|
—
|
91.5 score on a scale
Interval 83.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: No patients were deceased during the study period.
Assessing the difference time to death rates among study participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: No patients had metastases during study period.
Compare distant metastasis for both Endo-HDR and CRT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: No patients had progression during study period.
Compare progression free survival for both Endo-HDR and CRT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: No patients had locoregional recurrence during study period.
Compare locoregional control for both Endo-HDR and CRT.
Outcome measures
Outcome data not reported
Adverse Events
IMRT and Capecitabine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Endo-HDR
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMRT and Capecitabine
n=4 participants at risk
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 participants at risk
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection:
Endo-HDR: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus;
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
proctitis
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Skin and subcutaneous tissue disorders
sacral decubitis ulcer
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
General disorders
fatigue
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
General disorders
pain (NOS)
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Reproductive system and breast disorders
rectovaginal fistula
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
Other adverse events
| Measure |
IMRT and Capecitabine
n=4 participants at risk
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
Endo-HDR
n=5 participants at risk
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection:
Endo-HDR: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus;
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
|
|---|---|---|
|
Investigations
ANC elevated
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Investigations
alanine amino transferase increased
|
0.00%
0/4 • 60 months
|
40.0%
2/5 • 60 months
|
|
Blood and lymphatic system disorders
anemia
|
25.0%
1/4 • 60 months
|
60.0%
3/5 • 60 months
|
|
Investigations
aspartate amino transferase increased
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Investigations
bilirubin increased
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Investigations
creatinine decreased
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Investigations
creatinine increased
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
25.0%
1/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Reproductive system and breast disorders
dyspareunia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
dyspepsia
|
25.0%
1/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
General disorders
fatigue
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
fecal incontinence
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
GI hemorrhage
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Renal and urinary disorders
hematuria
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
hemorrhoids
|
50.0%
2/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
50.0%
2/4 • 60 months
|
60.0%
3/5 • 60 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Investigations
lymphocytes decreased
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Renal and urinary disorders
nocturia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
General disorders
pain (NOS)
|
25.0%
1/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Gastrointestinal disorders
proctitis
|
0.00%
0/4 • 60 months
|
40.0%
2/5 • 60 months
|
|
Gastrointestinal disorders
rectal pain
|
25.0%
1/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Renal and urinary disorders
urinary frequency/urgency
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Renal and urinary disorders
urinary retention
|
50.0%
2/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Investigations
WBC decreased
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Investigations
anorexia
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Cardiac disorders
atrial flutter
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Reproductive system and breast disorders
erectile dysfunction
|
50.0%
2/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
25.0%
1/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Gastrointestinal disorders
rectal bleeding
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Gastrointestinal disorders
rectal stenosis
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Reproductive system and breast disorders
vaginal dryness
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Reproductive system and breast disorders
vaginal pain
|
25.0%
1/4 • 60 months
|
0.00%
0/5 • 60 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
|
Investigations
weight loss
|
0.00%
0/4 • 60 months
|
20.0%
1/5 • 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place