Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03702985

Enrollment

160

Registered

2018-10-11

Start date

2018-05-28

Completion date

2020-03-01

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiotherapy, amifostine, irinotecan, capecitabine

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.

Interventions

RADIATIONRadiation

Pelvic Radiation: 50Gy/25Fx

DRUGCapecitabine

625mg/m2 bid Monday-Friday per week

DRUGIrinotecan

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

DRUGAmifostine

400mg/m2 per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0	during neoadjuvant chemoradiation.

Secondary

Measure	Time frame
the morbidity of late radiation proctitis	late radiation proctitis is measured 9 months after the end of chemoradiation.
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.

Countries

China

Contacts

Primary ContactJi Zhu, MD

leo.zhu@126.com+86-2164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026