Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma

NCT02801487 | Terminated Phase 1 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2015-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens along with concurrent chemotherapy (40 mg/m\^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

Conditions

Nasopharyngeal Carcinoma

Keywords

Carbon Ion Therapy; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Time interval from the start to 4 months after the completion of concurrent chemoradiotherapy

Secondary Outcomes (2)

• Overall survival of all patients

  From the diagnosis of local recurrence of NPC, a median of 2 years

• Progression-free survival of all patients

  Time Frame: From the completion of CIRT, a median of 2 years

Study Arms (1)

CIRT with concurrent chemo arm

EXPERIMENTAL

Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m\^2, weekly).

Radiation: Carbon ion radiotherapy (CIRT); Drug: Cisplatin

Interventions

Carbon ion radiotherapy (CIRT) RADIATION

Five dose levels (52.5GyE, 55GyE, 57.5GyE, 60GyE, 62.5GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 62.5 GyE are safely delivered, the recommended dose (or 62.5 GyE) will be the prescribed dose in the Phase II part of the study. Ninety-five percent (95%) of the isodose line should cover the GTV+3\~5mm.

CIRT with concurrent chemo arm

Cisplatin DRUG

Cisplatin (40mg/m\^2) monotherapy will be given weekly along with radiotherapy.

CIRT with concurrent chemo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed NPC
• Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
• Recurrence diagnosed more than 12 months after the initial course of IMXT
• Age ≥ 18 and \< 70 years of age
• Karnofsky Performance Score ≥70
• Willing to accept adequate contraception for women with childbearing potential
• Ability to understand character and individual consequences of the clinical trial
• Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

You may not qualify if:

• Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
• Presence of distant metastasis
• Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
• Pregnant or lactating women
• Patients who have not yet recovered from acute toxicities of prior therapies
• A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
• Refusal of the patient to participate into the study

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Heavy Ion Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 11, 2016
• First Posted: June 15, 2016
• Study Start: September 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)