Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2020-03-01

Brief Summary

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The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. Then it will depends which regimens the patient would receive according to his or her pathological results.

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Detailed Description

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Conditions

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Locally Advanced Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Capecitabine and Irinotecan without Amifostine

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Group Type ACTIVE_COMPARATOR

Radiation

Intervention Type RADIATION

Pelvic Radiation: 50Gy/25Fx

Capecitabine

Intervention Type DRUG

625mg/m2 bid Monday-Friday per week

Irinotecan

Intervention Type DRUG

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Capecitabine and Irinotecan with Amifostine

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) Amifostine: 400mg/m2 per week

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

Pelvic Radiation: 50Gy/25Fx

Capecitabine

Intervention Type DRUG

625mg/m2 bid Monday-Friday per week

Irinotecan

Intervention Type DRUG

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Amifostine

Intervention Type DRUG

400mg/m2 per week

Interventions

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Radiation

Pelvic Radiation: 50Gy/25Fx

Intervention Type RADIATION

Capecitabine

625mg/m2 bid Monday-Friday per week

Intervention Type DRUG

Irinotecan

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Intervention Type DRUG

Amifostine

400mg/m2 per week

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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Inclusion Criteria

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No