Trial Outcomes & Findings for A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma (NCT NCT02256982)

Results Overview

Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

90 Days

Results posted on

2016-04-13

Participant Flow

A total of 3 patients were enrolled between November 2014 and July 2015.

Participant milestones

Participant milestones
Measure	Resectable Disease * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist Gemcitabine Cisplatin Surgery: Surgical Resection and Lymphadenectomy	Unresectable Disease * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist Gemcitabine Cisplatin Radiation: Radiation Therapy
Overall Study STARTED	1	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Resectable Disease * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist Gemcitabine Cisplatin Surgery: Surgical Resection and Lymphadenectomy	Unresectable Disease * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist Gemcitabine Cisplatin Radiation: Radiation Therapy
Overall Study Disease Progression	0	1

Baseline Characteristics

A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resectable Disease n=1 Participants * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist Gemcitabine Cisplatin Surgery: Surgical Resection and Lymphadenectomy	Unresectable Disease n=2 Participants * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist Gemcitabine Cisplatin Radiation: Radiation Therapy	Total n=3 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 Days

Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.

Outcome measures

Outcome measures
Measure	Resectable Disease n=1 Participants * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) \-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist Gemcitabine Cisplatin Surgery: Surgical Resection and Lymphadenectomy	Unresectable Disease n=1 Participants * Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery\* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist Gemcitabine Cisplatin Radiation: Radiation Therapy
Number of Participants Post Operative/Radiation Therapy Complications	0 participants	0 participants

Adverse Events

Resectable Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unresectable Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ted Hong, MD

Massachusetts General Hospital

Phone: 617-726-6050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place