Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

NCT03702985 | Unknown Phase 2

• 1 other identifier: FDRT-R007
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiotherapy; amifostine; irinotecan; capecitabine

Outcome Measures

Primary Outcomes (1)

• the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

  during neoadjuvant chemoradiation.

Secondary Outcomes (3)

• Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire

  during neoadjuvant chemoradiation.

• pathological response rate

  Surgery scheduled 6-8 weeks after the end of chemoradiation.

• the morbidity of late radiation proctitis

  late radiation proctitis is measured 9 months after the end of chemoradiation.

Study Arms (2)

Capecitabine and Irinotecan without Amifostine

ACTIVE COMPARATOR

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.

Radiation: Radiation; Drug: Capecitabine; Drug: Irinotecan

Capecitabine and Irinotecan with Amifostine

EXPERIMENTAL

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.

Radiation: Radiation; Drug: Capecitabine; Drug: Irinotecan; Drug: Amifostine

Interventions

Radiation RADIATION

Pelvic Radiation: 50Gy/25Fx

Capecitabine and Irinotecan with Amifostine; Capecitabine and Irinotecan without Amifostine

Capecitabine DRUG

625mg/m2 bid Monday-Friday per week

Also known as: Xeloda

Capecitabine and Irinotecan with Amifostine; Capecitabine and Irinotecan without Amifostine

Irinotecan DRUG

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

Capecitabine and Irinotecan with Amifostine; Capecitabine and Irinotecan without Amifostine

Amifostine DRUG

400mg/m2 per week

Capecitabine and Irinotecan with Amifostine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Radiation; Capecitabine; Irinotecan; Amifostine

Intervention Hierarchy (Ancestors)

Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Zhen Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Zhu, MD

CONTACT

+86-2164175590; leo.zhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: October 11, 2018
• Study Start: May 28, 2018
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: January 23, 2019

Record last verified: 2018-10

Locations

CN (1)